Is Your Product Label Up to Code?

Posted by Lisa Capote | May 01, 2017 | 0 Comments

The FDA strictly regulates what you put on your product label if you're manufacturing or selling dietary supplements. Recently, a popular essential oil and aromatherapy company came under FDA fire for claims of treating and curing diseases. This is a clear violation of the Federal Food, Drug, and Cosmetic Act (FDCA). Here's what you need to know about what you should — and shouldn't — be putting on your product labels.

What Needs to Be On Your Product Label

The product label, in addition to your logo and marketing content, should have a Primary Display Panel. The Primary Display Panel should have:

  • Statement of Identity — this is simply a statement of what the item is. It generally uses the most commonly recognized names for an item.
  • Statement of Net Quantity — your PDP should state the net quantity of your product contained within the packaging. Depending on what your supplement is, you can display net quantity in weight, measure, or both.
  • Ingredients List — this is perhaps the most crucial component of your Primary Display Panel. Your ingredients should be listed prominently on the package. Arrange them in order of greatest amount used within the product to least amount used.
  • Nutrition Information — your label should contain any nutrition information that is applicable to your product. This labeling requirement is very similar to food labeling requirements, since dietary supplements are typically ingested.
  • Contact Information — the FDA requires that the product manufacturer or distributor's name, address, and other contact information is displayed prominently on the label.

What Not to Include on Your Product Label

While there are some things that you absolutely want to be sure is on your product label, there are a few things that you want to leave out. Namely, any claims or guarantees that the product will do a certain thing. For example, if you are manufacturing a weight loss supplement, you do not want to guarantee weight loss on your packaging. Also, if you are selling an essential oil, you don't want to make any claims that the oils treat or cure diseases or illnesses.

When to Contact an Attorney

It's always in your best interest as the manufacturer of a product that is regulated by the FDA in some way to have the label examined by an experienced attorney. At, we can help you ensure that your label meets FDA requirements and leaves out anything that could potentially cause you to be sent a warning letter. Contact us today for a consultation by calling 786.871.5680,

About the Author

Lisa Capote

Ms. Capote is the founder and Managing Partner of Capote Law Firm. She founded the minority, woman owned law firm in 2006 with the goal to provide quality service to FDA regulated companies. Since that time her practice has grown to include other US federal agencies as well as an international trade component.


There are no comments for this post. Be the first and Add your Comment below.

Leave a Comment


AV Preeminent Rating

10.0Lisa Capote


Lisa Capote
Rated by Super Lawyers

loading ...

Copyright © 2021 Capote Law Firm

This website is intended solely to convey general information about Capote Law Firm and should not be construed as legal advice. Neither your use of this site nor your transmission of electronic mail to Capote Law Firm or any of its lawyers will create an attorney-client relationship. The formation of an attorney-client relationship requires satisfaction of multiple factors such as resolution of possible conflicts of interest, an appropriate fee arrangement, and mutual agreement on the terms of the engagement. This Website should not be interpreted as an offer by Capote Law Firm or any of its attorneys to practice law in any jurisdiction in which Capote Law Firm or the attorneys are not properly authorized to do so. The hiring of a lawyer is an important decision that should not be based solely upon advertisements. Before you decide, ask us to send you free written information about our qualifications and experience or call us to discuss any specific questions.